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Recruiting NCT06056037

Making ART Work Among Brazilian Youth

No phase Interventional Hiv Adherence, Medication

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental: Making ART Work, Standard of Care.
Who it may be relevant to
Registry conditions: Hiv, Adherence, Medication. Basic parameters: 18 years — 24 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Making Universal, Free-of-charge Antiretroviral Therapy Work for Sexual and Gender Minority Youth in Brazil

Overview

This study seeks to develop and pilot test a theory-based, integrated technology and counseling intervention to improve ART adherence among sexual and gender minority (SGM) young people living with HIV (ages 18-24) in Rio de Janeiro, Brazil. The intervention aims to improve social support, self-efficacy for taking ART, and teach skills for problem-solving barriers to promote better adherence.

Detailed description

Background. Sexual and gender minority (SGM) youth account for the largest number of incident HIV infections in Brazil. Although HIV can be managed with ongoing antiretroviral therapy (ART), exceptionally high levels of adherence are required. Brazil has implemented a comprehensive HIV treatment program with broad access to ART, but this program does not specifically address barriers to optimal ART adherence, particularly for SGM youth who experience many challenges taking their medication as prescribed. Overview. This application seeks to develop and pilot test a theory-based, integrated technology and counseling intervention to improve ART adherence among HIV infected SGM youth (ages 15-24) in Rio de Janeiro, Brazil. The intervention aims to improve social support, self-efficacy for taking ART, and teach skills for problem-solving barriers to promote better adherence. To inform the content, structure, and format of the proposed intervention, the MPIs recently conducted focus groups with SGM youth (N = 18) and key informant interviews (N = 7) with medical providers and staff at local HIV service organizations working closely with SGM youth in Rio de Janeiro. Across focus groups and key informant interviews there was universal agreement that an intervention should capitalize on and enhance social support structures among SGM youth, and address their specific concerns, especially as related to the individual (e.g., ART side effects, mood, substance use), social (e.g., HIV/SGM stigma), and structural (e.g., clinic hours, transportation challenges) barriers that they regularly face. Theoretical Model. The intervention is guided by Social Cognitive and Social Support Theories and is grounded in the social and contextual realities of SGM youth living with HIV in Brazil. Specifically, social support is emphasized and informational, problem-solving and cognitive-behavioral "steps" are addressed over 4-group adherence counseling sessions, which include short video vignettes that seek to normalize adherence challenges. In addition, daily tailored SMS text messages are delivered as part of the intervention to facilitate social-cognitive cues to take medications as prescribed. Research Plan. Phase 1: Refine and enhance participant acceptability of the intervention and resolve any issues with intervention delivery/implementation; this will be achieved by convening and obtaining feedback from our youth community advisory board throughout this phase and subsequent phases; and by conducting an open-phase pilot with up to 12 SGM youth, with post-intervention exit interviews, as well as obtaining feedback from our youth community advisory board throughout this and subsequent phases. Phase 2: Examine, in a pilot randomized controlled trial, the feasibility, acceptability and potential impact of the proposed intervention among approximately 72 SGM youth who will be equally randomized to the intervention or a standard of care control condition with standard of care. The outcomes are improved ART adherence, retention in care and viral load suppression. Study assessments will be conducted at baseline, 3- and 6-months.

Interventions

  • Behavioral Experimental: Making ART Work
    A culturally tailored, theoretically grounded provider-facilitated group-based social support intervention (4 sessions) that emphasizes a collective approach to ART adherence and includes establishing a common understanding of ART, identifying potential barriers to ART adherence with a focus on social and structural barriers (e.g., stigma, relationship influences, family support, economic stressors), developing practical strategies to increase self-esteem and self-efficacy to enhance ART adheren
  • Behavioral Standard of Care
    Prior to randomization, all participants will meet briefly with a counselor to assess current needs for standard HIV primary care and referrals to social and/or health (including mental health) services. If participants do not have a primary HIV care provider, they will be linked to a provider at INI-Fiocruz or their preferred clinic, where they can access free HIV care through the no-cost universal access program of the Brazilian Public Health System. Additionally, the counselor will provide ne

Primary outcome measures

  • Feasibility: number of participants who have at least one follow up visit [Time frame: 6 months]
  • Feasibility: mean number of intervention sessions attended [Time frame: 3 months]
  • Acceptability: mean score on the Client Satisfaction Questionnaire scale (CSQ-8) [Time frame: 3 months]
  • Medication adherence - proportion of participants with presence of tenofovir in urine using a point-of-care lateral flow immunoassay (LFA) method [Time frame: 6 months]
  • Medication adherence - proportion who have received all ART prescriptions over the course of follow up according to pharmacy dispensing records (SICLOM national registry) [Time frame: 6 months]
Secondary outcome measures (2)
  • Plasma viral load - mean viral load as obtained through the SISCEL database (national registry) [Time frame: 6 months]
  • Retention in HIV care: proportion who have been in continuous care according to 1) at least 1 or more routine HIV visits, 3 months apart or more, (2) receiving 1 or more CD4 tests; and (3) receiving 1 or more viral load tests [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • between 18 and 24 years of age
  • assigned male sex at birth
  • identify as a gay or bisexual man, or a transgender woman or another gender identity along the feminine spectrum
  • self-report living with HIV, and verified by medical chart review,
  • self-report currently taking or prescribed ART for > 3 months
  • self-report missing 2 or more doses of ART medications in any given week in the past month OR not virally suppressed (i.e., >40 copies/mL in past 3 months; via national outpatient data \[SISCEL\] or plasma viral load testing)
  • owns a cell phone or willing to use one as part of the study

Exclusion criteria

  • unable to give informed consent due to cognitive limitation, severe mental/physical illness or intoxication
  • unable to read and/or write to an extent that would limit their ability to comprehend the informed consent
  • lived in the greater Rio de Janeiro area for < 3 months or planning to move outside the area within the next year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Evandro Chagas National Institute of Infectious Diseases (INI) Oswaldo Cruz Foundation (FI — Rio de Janeiro

Identifiers

NCT: NCT06056037 · 2103002951 · R34MH126894

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗